Fish Company Sued by FDA Has History of Food Safety Concerns

U.S. Food and Drug Administration records show that a California fish company currently in trouble with regulators for alleged violations of food safety codes has a history of inspection failures, including insanitary conditions.

An FDA Warning Letter to Fujino Enterprises Inc. of Montara, California, notified company president Eriko Fujino in November 2010 that the company’s seafood processing facility in Princeton-By-The-Sea
was not abiding by an acceptable Hazard Analysis and Critical Control Point (HACCP) plan. “Accordingly, your refrigerated, vacuum packaged, ready-to-eat hot smoked and cold smoked salmon is adulterated, in that it has been prepared, packed, or held under insanitary conditions,” the Warning Letter said.

The document, examined by Food Safety Bulletin in the wake of a 2012 federal lawsuit against Fujino Enterprises, discussed lax monitoring and temperature controls that were seen by FDA as a risk for the formation and spread of the pathogens Staphylococcus aureus and Clostridium botulinum.

The Warning Letter was based on findings from a July 2010 inspection that also found significant lapses in record keeping at the plant and sanitation problems.

The FDA, in conjunction with the U.S. Department of Justice, is in litigation against against Fujino, which does business as Blue Ocean Smokehouse, in an attempt to shut down the company’s fish processing. The demand for a permanent injunction is being heard in U.S. District Court.

Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs, said the legal action was taken because Fujino has ignored warnings by the FDA and the California Department of Public Health ”by continuing to sell seafood that puts consumers’ health at risk.”

The injunction was sought after federal regulators found continued problems in fish processing during an inspection late last year. Investigators at that time found Listeria monocytogenes on food-contact and non-food-contact surfaces in the food processing areas.

The Warning Letter from 2010 gave several detailed examples of conditions that inspectors found unacceptable. For instance, one investigator observed that the company’s water reservoir its ice machine was corroded and contained a greenish, slimy substance. An investigator also observed that plastic bins used to store fish and fishery products were cleaned on the floor of the production area.

Cross-contamination hazards included a hose used in the production area being stored on the floor.

The Warning Letter is signed by Barbara J. Cassens, FDA District Director, San Francisco District.